Health
FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans
This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).
A U.S. Food and Drug Administration (FDA) panel rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care.
On June 4, the advisory committee voted 10-1 against the overall benefits of MDMA when used to treat PTSD, according to the Associated Press.
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During the nine-hour-long hearing — which was held in Silver Spring, Maryland — the panel addressed some concerns about study flaws, unclear data and potentially damaging side effects, leading to another 9-2 vote against drug efficacy.
The drug application for psychedelic-assisted therapies was filed by Lykos Therapeutics in California earlier this year.
“When I heard the verdict, all I could think about was the hopes of those veterans being dashed … and not having a solution for them,” one advocate said. (iStock)
The company expressed its disappointment in the FDA’s decision in a statement on June 4.
“We are disappointed in today’s vote, given the urgent unmet need in PTSD, and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Lykos Therapeutics CEO Amy Emerson.
“We are disappointed in today’s vote, given the urgent unmet need.”
“We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the health care system, if approved.”
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In a statement sent to Fox News Digital, the FDA echoed the intent for an ongoing review of the drug application.
“The FDA appreciates the input from the Psychopharmacologic Drugs Advisory Committee,” an FDA spokesperson wrote in an email. “Following the meeting, FDA career staff will take the committee’s input into account as they continue their review of the new drug application.”
An FDA panel has rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care. (iStock)
Juliana Mercer, a 16-year Marine Corps veteran and director of the nonprofit Healing Breakthrough, who is based in San Diego, has been a leading advocate of psychedelic-assisted therapies in treating mental health challenges.
In an interview with Fox News Digital, Mercer said the verdict felt like a “big gut punch.”
She added, “When I heard the verdict, all I could think about was the hopes of those veterans being dashed … and not having a solution for them.”
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At the hearing, Mercer said there were “quite a few large veteran organizations that shared the great need for a solution to PTSD.”
“There were also individual veterans who had undergone the therapy and talked about this life-saving treatment they received,” she added.
U.S. Marine Juliana Mercer is pictured deployed in Helmand Province, Afghanistan, in 2010. The now-veteran also battled PTSD. (Juliana Mercer)
One Marine veteran spoke to the panel about the phone calls he has received from veterans asking, “How do I get this treatment?”
“I get those same calls,” Mercer said. “Veterans have heard that this works. They’ve seen the data and the science, and they’ve been desperately waiting for this approval.”
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Following the decision, Mercer said, “I just had a pit in my stomach, thinking about those veterans … who shared their testimony. It took me about 48 hours to go from basically grief to recognizing that we had an uphill battle, and I was ready to do everything it took to win this fight.”
Juliana Mercer, pictured, testified on Capitol Hill in November 2023 to advocate for psychedelic-assisted therapies in front of he House Committee for Veterans’ Affairs. (Juliana Mercer)
Mercer noted that the conversation with the advisory committee veered from data and facts into a “conversation about drug abuse, integrity and motivation.”
“They were saying there was not enough data and facts to approve it, basically,” she said. “This is the first time we’ve had something that actually has science and data behind it to actually heal or eliminate a PTSD diagnosis — and they refuse to look at that.”
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Mercer said she is “holding out hope” that this decision will be overruled. “We haven’t had a new PTSD drug for over 20 years. And the ones that we have are not as effective as we need them to be.”
“There is a huge downside in terms of unregulated recreational uses.”
“We’re losing over 6,000 veterans a year. We’ve lost over 130,000 veterans here on American soil to suicide since 2001, since the global war on terror started.”
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The Department of Veteran Affairs (VA) currently has 13 MDMA-based trials underway, according to Mercer.
As this decision isn’t the final call, the FDA said it will continue to work with Lykos Therapeutics to address its concerns until the new decision deadline on August 9.
Both MDMA and psilocybin-assisted therapies (also known as ecstasy and magic mushrooms) will be studied by the VA. (iStock)
In a statement sent to Fox News Digital, VA Press Secretary Terrence Hayes said that while the Washington, D.C. agency “closely” monitors the FDA’s decisions, the VA “cannot comment on the recommendations of the FDA advisory committee or the FDA’s pending decision on a new drug application.”
“VA is committed to high-quality research that safely promotes the health of our nation’s veterans,” Hayes wrote.
“In line with this goal, as announced in January, VA plans to conduct additional studies under stringent protocols at various facilities to evaluate if psychotherapy in combination with compounds such as MDMA and psilocybin are effective for treating veterans with post-traumatic stress disorder and other mental health conditions.”
“We’re losing over 6,000 veterans a year,” one advocate said. “We’ve lost over 130,000 veterans here on American soil to suicide since 2001, since the global war on terror started.” (iStock)
Hayes added, “VA may provide agency research funding to larger studies investigating these novel therapies, including those that involve novel ways of administering the therapy with the intent of achieving maximum benefit to Veterans, while minimizing risks.”
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, interviewed two of the country’s top researchers on psychedelics.
He spoke with Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Research at Mt. Sinai in New York, and Dr. Charles Marmar, director of the PTSD research program at NYU Langone, earlier this year.
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“They agree there is therapeutic potential if very carefully studied under very strict medical guidance, but there is a huge downside in terms of unregulated recreational uses,” Siegel told Fox News Digital at the time.
“Both doctors see likely therapeutic value to psychedelics if carefully managed by medical experts.”
Health
Experimental Alzheimer’s drug could reduce alcohol withdrawal damage, researchers say
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An investigational dementia drug may also ease alcohol withdrawal by calming the brain inflammation linked to addiction and relapse.
That’s according to researchers at the University of Kentucky, who studied an experimental medication called MW150 that targets a brain inflammation pathway known as p38α MAPK.
The drug, which has not yet been approved, is designed to treat mild to moderate Alzheimer’s disease.
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Scientists believe neuroinflammation may contribute to relapse risk and long-term neurological damage in people with alcohol use disorder.
In laboratory and animal-model experiments, MW150 was found to reduce certain inflammatory markers during alcohol withdrawal.
An investigational dementia drug may also ease alcohol withdrawal by calming the brain inflammation linked to addiction and relapse. (iStock)
The work, which was published in the journal Alcohol, came from the University of Kentucky’s Sanders-Brown Center on Aging, led by neuroinflammation researcher Linda Van Eldik.
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Caleb Bailey, Ph.D., co-author of the study and a researcher in Van Eldik’s lab, said the study provides “biological plausibility” that MW150 could mitigate neuroinflammation arising from alcohol withdrawal.
Alcohol use disorder is difficult to treat because of high relapse rates, especially during withdrawal, according to Bailey.
Alcohol use disorder is difficult to treat because of high relapse rates, especially during withdrawal, according to the researchers. (iStock)
“If follow-up experiments reveal similar anti-inflammatory effects of MW150 in animal models of alcohol use disorder, it would provide a strong rationale for development of MW150 as a treatment for those struggling with chronic alcohol relapse due to alcohol withdrawal,” he told Fox News Digital.
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Along with a related drug called Neflamapimod, MW150 is already being investigated in clinical trials as a potential therapy for dementia and other neurodegenerative conditions, the researchers noted.
“That gives this work added significance,” Bailey said. “Because these compounds are already further along in development for other neurological diseases, it raises the possibility that they could someday be repurposed more efficiently for alcohol-related conditions if future studies continue to show promise.”
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There were some important caveats to the research, including that it was conducted in cell culture and animal models.
“Because they are ‘dish’-based models, they provide limited information regarding what happens in the full organism – or even the full brain for that matter,” Bailey said.
MW150, along with a related drug called Neflamapimod, is already being investigated in clinical trials as a potential therapy for dementia and other neurodegenerative conditions. (iStock)
“A series of follow-up studies in living animals is required to more fully understand how future MW150 treatment in alcohol use and withdrawal affects systemic health and/or alcohol consumption.”
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Dr. Amy Swift, deputy chief medical officer at Silver Hill Hospital in Connecticut, was not involved in the study but shared her reactions to the findings.
“Although detoxification using tapering doses of medication has long been considered the evidence-based first step in treating alcohol use disorder, its impact on the long-term trajectory of a person’s drinking behavior has been limited,” she told Fox News Digital.
“Minimizing alcohol consumption … is the best strategy for staying healthy.”
“Put simply, detoxification does not treat alcohol use disorder itself; rather, it prevents the potentially fatal complications of alcohol withdrawal.”
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Adding supportive medications — especially those intended to improve overall brain health — could address an important gap in early treatment of detoxification, according to Swift.
“It is worthwhile to investigate whether reducing neuroinflammation could improve a patient’s ability to engage in treatment earlier in recovery and, in turn, meaningfully alter their long-term relationship with alcohol,” an expert said. (iStock)
“Given the profound inflammatory effects alcohol has across multiple organ systems, it is worthwhile to investigate whether reducing neuroinflammation could improve a patient’s ability to engage in treatment earlier in recovery and, in turn, meaningfully alter their long-term relationship with alcohol,” she added.
Bailey emphasized that no amount of alcohol consumption is good from a physical health standpoint.
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“We don’t currently have robust pharmacological treatments to mitigate damage caused by chronic alcohol consumption,” he said. “Minimizing alcohol consumption, therefore, is the best strategy for staying healthy.”
As the MW150 compound continues to be studied for dementia patients, Bailey saud, “information regarding the interaction between these drugs and alcohol — for better or for worse — will be important for patient outcomes.”
Health
One type of sitting may pose greater dementia risk than another, study suggests
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For years, researchers have believed prolonged sitting could raise dementia risk — but new findings suggest the type of sitting may matter more than previously thought.
The research, which was published in the American Journal of Preventive Medicine in March, found that replacing mentally passive sedentary behavior with mentally active sedentary behavior was associated with a significant reduction in dementia risk.
Mentally active sedentary behaviors could include reading, office work and other activities that keep the brain engaged while sitting, while mentally passive behaviors may include watching television or other low-engagement screen activities.
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To gather the findings, Swedish researchers analyzed data from more than 20,000 adults between ages 35 and 64 who were tracked over a 19-year period, between 1997 and 2016, according to a press release.
Participants answered questions about their sitting habits, physical activity and other lifestyle behaviors, while dementia diagnoses were identified using Swedish health and death records.
Researchers emphasized that how people use their brains while sitting may matter more than previously understood. (iStock)
Mentally active sedentary behavior was associated with “a significant reduction in dementia risk” compared to more passive sitting activities.
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Although the study was based in Sweden, the release said the findings “are likely generalizable to a wider global population” and could help “inform public health guidelines and preventive strategies to reduce dementia.”
In a statement, lead researcher Dr. Mats Hallgren of Sweden’s Karolinska Institute said the study highlighted major distinctions between passive and mentally engaging sedentary habits when it comes to brain health.
The research tracked more than 20,000 adults over nearly two decades to examine links between sitting habits and dementia. (iStock)
“While all sitting involves minimal energy expenditure, it may be differentiated by the level of brain activity,” said Hallgren.
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“How we use our brains while we are sitting appears to be a crucial determinant of future cognitive functioning and, as we have shown, may predict dementia onset.”
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Sedentary behavior is a “ubiquitous but modifiable risk factor for many health conditions, including dementia,” according to the researcher.
“Our study adds the observation that not all sedentary behaviors are equivalent; some may increase the risk of dementia, while others may be protective,” he added. “It is important to remain physically active as we age, but also mentally active — especially when we are sitting.”
The findings suggest not all sitting behaviors are equal when it comes to protecting long-term brain health. (iStock)
The CDC projects that by 2060, nearly 14 million American adults will have Alzheimer’s disease.
One recent study published by the Alzheimer’s Association found that a person’s biological age may be tied to dementia risk.
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Researchers also recently found that a higher intake of unprocessed meat may protect against dementia in older people who have a variant of a certain gene.
Health
5 common walking mistakes that could hurt your progress, according to an expert
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Walking is a great way to get the body moving and clear the mind — but if you’re doing it wrong, it may do more harm than good.
That’s according to Dr. Milica McDowell, author of the new book “Walk,” a guide to getting the most out of walking.
The Montana-based doctor of physical therapy, who specializes in lower extremity and orthopedics, shared in an interview with Fox News Digital how powerful walking can be.
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“Walking has incredible health benefits for your wellness today and your longevity tomorrow,” she said. “And it’s something that’s at an all-time low since the pandemic.”
“Walking improves every system in your body – gut, musculoskeletal, mental health, your hormones – and so it has an incredible power to help optimize how you’re doing.”
“Walk,” co-authored by physical therapist Milica McDowell, explores how walking can improve longevity, mobility, mental well-being and overall fitness. (Amelia Anne Photography; Hachette Book Group/Alexander Ryabintsev)
McDowell added that walking is a “phenomenal way” to support a weight-loss journey, as it’s low-impact and low-intensity. It can also boost creativity and reduce stress.
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While the health benefits of walking are evident, McDowell warned of some mistakes that could reverse progress.
No. 1: Walking while scrolling
Escaping our phones can sometimes feel impossible, but if there’s ever a time to be on do-not-disturb, it’s during a walk, according to McDowell.
Walking while scrolling is “really dangerous,” she cautioned, as you’re less aware of your surroundings and more susceptible to accidents.
Walking while scrolling is a danger to public health, the expert says. (iStock)
“You could step in a pothole. You could get hit by a car. You could trip over something. You could bump into someone,” she said. “Walking and scrolling is actually a bit of a public health crisis.”
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Scrolling also puts the neck in a downward position, making the head heavier, which changes your posture “from the top down,” McDowell said. “That can be a problem if you’re someone who struggles with neck pain, back pain or shoulder pain.”
No. 2: Wearing the wrong shoes
McDowell recommends wearing a proper shoe designed specifically for walking to support the feet, promote healthy alignment and protect musculoskeletal health.
The shoe should be “shaped like a foot” so that the toes have room to spread within a wide toe box, she said.
Having space between each toe activates more muscles in the foot and creates a “more healthy walking gait,” according to the expert.
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More than 60% of adults wear the wrong shoe size, according to McDowell, and sizing can vary significantly between brands and manufacturers. She recommends getting measured by a professional to ensure the optimal fit.
No. 3: Not balancing your routine
Walking engages important muscles that support stability and mobility, including the glutes, which help propel the body forward with each step.
But walking shouldn’t be your only form of exercise, experts say. Incorporating strength training and other forms of movement can help prevent overuse injuries, improve balance and build overall fitness.
A well-rounded fitness routine will boost the health benefits of walking, the expert said. (iStock)
“A health stack includes drinking enough water, having healthy nutrition and sleeping adequately — and walking can be added to the other activities,” she said.
Pairing walking with activities like weightlifting, pickleball, dancing or CrossFit can help create a more balanced fitness routine, according to McDowell, and are all part of building a strong “health stack.”
“A health stack includes drinking [enough] water, having healthy nutrition, sleeping adequately — and walking can be added to the other activities,” she said.
No. 4: Not considering walking speed
The speed at which we walk may tell us more about our health than we think.
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Walking speed is the sixth vital sign of health, according to McDowell. These clinical measurements also include blood pressure, heart rate and body temperature.
If your walking speed begins to decline, this could be a marker of underlying health conditions up to seven years before they occur.
A decline in walking speed could be an early warning sign of an underlying health condition. (iStock)
While most people walk at about 90 to 100 steps per minute, translating to about three miles per hour, McDowell suggested increasing your speed to reap “higher level benefits.”
This might mean taking a brisk walk at about 120 to 130 steps per minute, or three and a half to four miles an hour.
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“That can be a place where you get higher level payoff, including more calories burned, if you’re on a weight-loss journey,” she said.
No. 5: Not staying consistent
McDowell emphasized the importance of staying consistent with your walking routine.
A daily walk will have bigger payoffs than only walking once or twice a week. The expert likened walking to basic hygiene, such as brushing your teeth.
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“Everyone is at different places on their walking journey,” she said. “Don’t set the 10,000 steps per day benchmark. That is a marketing myth … Go ahead and find a step count that works well for you, maybe between 5,500 and 7,500.”
Efficiency is everything
McDowell summed up that each walk should be efficient.
“If you are an efficient walker, you are graceful, you are not wasting energy, you are walking balanced no matter your height, your weight or your age,” she said.
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As the wellness movement has emphasized the importance of just moving, McDowell commented that walking is a “pinnacle activity” in this push.
“People are recognizing that these softer, more consistent activities can provide a lot of benefit for our physical and mental health,” she said.
McDowell encourages walking with a friend for added social benefit. (iStock)
“You don’t have to go and crush yourself in the gym. You don’t have to be dripping sweat … It’s something you can do for periods of time throughout the day, little ‘snacks’ that all add up, or you can take longer walks depending on what time is available to you.”
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Walking can also be a positive social experience done with friends and loved ones, McDowell noted. This is particularly important for seniors who can benefit from the combined physical activity and social interaction.
“Walking with an older adult can help combat loneliness,” she said. “It can also help improve balance and reaction time, and reduce fall risk.”
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